Assessment of the Safety and Performance of Elbow Supports in the Context of Epicondylitis or a Return to Sport After Sprain
NCT ID: NCT05552209
Last Updated: 2023-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2022-09-21
2023-10-31
Brief Summary
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The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon elbowMID500 and elbowSTRAP products to demonstrate safety and performance of these devices in a real-world setting.
Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Decathlon elbowMID500 and elbowSTRAP devices and support peer-reviewed publications on products performance and safety.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Orthosis group 1
Use of Elbow Mid 500 device during sport practice
Elbow MID 500
15 patients will be included in this group and will used the medical device Elbow MID 500 during sport practice (at least 2 sport sessions per week), for 6 weeks.
Control group 1
Control group of the Elbow Mid 500 group - no medical device used during sport practice
Control group Elbow MID 500
15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device Elbow MID 500), for at least 2 sport sessions per week during 6 weeks.
Orthosis group 2
Use of Elbow Strap device during sport practice
Elbow STRAP
15 patients will be included in this group and will used the medical device Elbow STRAP during sport practice (at least 2 sport sessions per week), for 6 weeks.
Control group 2
Control group of the Elbow Strap group - no medical device used during sport practice
Control group Elbow STRAP
15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device Elbow STRAP), for at least 2 sport sessions per week during 6 weeks.
Interventions
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Elbow MID 500
15 patients will be included in this group and will used the medical device Elbow MID 500 during sport practice (at least 2 sport sessions per week), for 6 weeks.
Control group Elbow MID 500
15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device Elbow MID 500), for at least 2 sport sessions per week during 6 weeks.
Elbow STRAP
15 patients will be included in this group and will used the medical device Elbow STRAP during sport practice (at least 2 sport sessions per week), for 6 weeks.
Control group Elbow STRAP
15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device Elbow STRAP), for at least 2 sport sessions per week during 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* Subject has an acute epicondylitis (stage 1 or 2) OR a recent mild elbow sprain
* Subject performs regular physical activity (minimum of 2 sessions of 10 minutes per week)
* The current condition of his/her elbow allows the subject to resume usual physical activity
* Subject has been informed and is willing to sign an informed consent form
* Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (6 weeks)
* Subject is affiliated to the French social security regime
Exclusion Criteria
* Subject has worn a support (elbow brace or articulated orthosis) in the last month during his/her sport practice
* Subject has resumed regular physical activity since his/her recent injury
* Subject has any medical condition that could impact the study at investigator's discretion
* Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastane, polyester, elastodiene) • Adult subject to legal protection measure
18 Years
99 Years
ALL
No
Sponsors
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EFOR, France
INDUSTRY
Decathlon SE
INDUSTRY
Responsible Party
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Principal Investigators
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Valérie WIECZOREK
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Lille
Locations
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Centre Hospitalier de Boulogne sur Mer
Boulogne-sur-Mer, , France
Centre de rééducation et de balnéothérapie Kinés Faches
Faches-Thumesnil, , France
Centre Hospitalier Universitaire de Lille
Lille, , France
Cabinet de kinésithérapie du Belvédère
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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elbowMID500-STRAP
Identifier Type: -
Identifier Source: org_study_id
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